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Effects of EGCG-Enhanced Extra Virgin Olive Oil on Endothelial Function

 
Study IDNCT00865787
StatusRecruiting
Phase-
SourceClinicalTrials.gov
StartedFeb 1 2008
Last UpdatedSep 9 2009
Estimated CompletionSep 9 2009
 
About this clinical study

Summary

This study is being done to determine if the use of EGCG-Enhanced Extra Virgin Olive Oil in a daily diet will improve endothelial function.

Condition / Disease

Atherosclerosis

Study Outcomes

  • Supplementation with enhanced olive oil will improve endothelial function as assessed by the reactive hyperemia peripheral arterial tonometry (RH-PAT) in patients with coronary artery disease (CAD) risk factors and endothelial dysfunction
  • Supplementation of EGCG enhanced olive oil will reduce peripheral markers of endothelial dysfunction and inflammation, oxidative stress and inflammation

Description

Patients will be randomized to receive either placebo ROO (refined olive oil) or study solution EGCG-EVOO (EGCG enhanced extra-virgin olive oil) over the four month study period.

Sponsors

Primary SponsorMayo Clinic
 
CollaboratorsOlivi Agri Team Srl- Grosetto, Italy
University of Florence

Enrollment

Overview

Gendermale, female
 
Target Enrollment50
 
Recruiting Healthy VolunteersYes

Locations

Mayo ClinicRochesterMN

Criteria


Inclusion Criteria:

  • Patients will be included in the study if they have an abnormal endothelial function study. This is defined at our institution as an RH-PAT index of less than 2. Patients will undergo two RH-PAT analyses and included abnormal values are obtained on either one or both tests. Only patients who provide written informed consent will be included.

  • Exclusion Criteria:

  • Patients with normal baseline endothelial function studies defined as RH-PAT index >2 will be excluded.
  • Patients with uncontrolled hypertension >180/100 while on medication on initial evaluation will also be excluded.

    Contact

    Overall Contact

    Jasmine Sexton, BS, BAS - 507-538-4665

    Investigators

    Amir Lerman, MDPrincipal Investigator
     

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